Copy
RESCUE-ASDH Newsletter October 2016            @rescueasdh                    View this email in your browser

Newsletter October 2016


Updates on recruitment and trial related matters


Dear <<First Name>> <<Last Name>>

Thank you for your continuing support of the RESCUE-ASDH Trial!

As of today...

  • 129 patients have been randomised from 22 UK sites 
  • 146 patients have been enrolled in the observational study cohort
  • 25 centres –each with a trainee co-PI- are now open to recruitment in the UK  and US
  • 12 international centres are currently in set up
  • Please keep screening all patients with ASDH for eligibility!

Many thanks to all PIs / trainee co-PIs / research staff for your ongoing efforts to randomise all eligible patients.


Best wishes,

RESUE-ASDH Trial Management Group

In this edition:

The issue of equipoise 

RESCUEicp Results 

Upcoming Events 

CRF version 4.0 

Literature Highlights 

Additional Support 

 Randomisation Details 

Recruitment Details 

Congratulations to Jonathan Pollock (PI), Anouk Borg and Geoffrey Tipper (Co-PIs) for opening the RESCUE-ASDH Trial for recruitment at Romford and randomising their first patient!
Congratulations to Roddy O'Kane (PI) and Michael Canty (Co-PI) and their team for opening the RESCUE-ASDH Trial for recruitment at Queen Elizabeth University Hospital in Glasgow.

On the issue of equipoise...

 

In this edition we have summarised the main points of the 'equipoise discussion'. If you would like to comment on the points, please send us an email at info [at] rescueasdh.org.
 

 The aim of the study is to randomise patients to bone flap replacement versus primary decompressive craniectomy following evacuation of an acute subdural haematoma.
 It is clear that there is a proportion of patients who cannot be randomised because the brain is too swollen and there is no doubt that the brain flap cannot be replaced in these patients.
 There is also a proportion of elderly patients with very slack brains in whom it is both reasonable and sensible to replace the bone flap.
 Please randomise all other patients.
 It needs to be recognised that while there is variation in the degree of uncertainty amongst individual surgeons there is considerable uncertainty across the whole clinician population.
 This has been demonstrated in the pre-trial surveys (1,2).
 It has also been demonstrated by the fact that >125 patients have been randomised and the study has progressed from the pilot to the main phase.
 Uncertainty varies between clinicians and neurosurgical centres with major variation in the proportion of randomised versus observational patients between centres.

 Although the brain may be relaxed at the end of the operation this does not indicate that it will not swell in the hours and days following surgery.

 Although cases where the bone flap is subsequently removed may be uncommon, this does not equate to better outcome; these patients may still have benefitted from primary decompressive craniectomy.
 Overall, although some clinicians have strong opinions with a narrow degree of uncertainty we should all accept that others have a broader range of uncertainty which has led to randomization of >125 patients.
 Finally, despite variation in the degree of uncertainty between clinicians no one knows what the study will show and the data monitoring committee recommends on-going recruitment.








 
"Replacing the bone flap for an ASDH in the context of trauma? Why? You should always leave it out..."
-US Neurosurgeon




 
"I don't see why you should leave the bone flap out if the brain is not bulging beyond the dural plane..."
-UK Neurosurgeon




 
"I don't know...that depends on the consultant on-call..."
-Neurosurgical trainee




 
"This is our practice in this unit...I have not been in equipoise during surgery. "
-Neurosurgical trainee




 
"Surgical RCTs are too difficult..."
-UK Neurosurgeon




"Surgeons are trained not to be in equipoise in theatre..."
-UK Neurosurgeon


RESCUEicp Results Published


The results from our sister study, the Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intracranial Pressure (RESCUEicp) trial, were published online in The New England Journal of Medicine on September 7.

We have listed the key links below:

 The NEJM paper can be found here and the accompanying editorial is here
 The University press release explaining the importance of the findings is here
 Medscape coverage with comments by Peter Hutchinson here
 The first oral presentation of the RESCUEicp trial results presented at the EANS 2016 meeting in Athens is now online, and can be viewed here.
 The NEJM QuickTake video summarising the RESCUEicp study results can be found here

Upcoming Events

 The study will be presented at the following conferences:

  • Italian Society of Neurosurgery 2016, 19-20th October 2016, Rome, Italy
  • NeuroTrauma Conference 2016, 20th October 2016, London, UK.
  • Euroacademia Multidisciplinaria Neurotraumatologica, 20-22nd October 2016, Serbia
  • BNRG Meeting, 2nd-3rd March 2017, Birmingham, UK
  • Cambridge Trauma Conference 2017, 8th-10th March 2017, Cambridge, UK.
  • Investigator Meeting for the RESCUE-ASDH Trial, TBC - March, UK.
  • SBNS Spring Meeting, 29-31 March 2016, Oxford, UK

CRF version 4.0
Main Changes to note

Baseline CRF:

  • Demography and Behavioural sections reduced
  • Handedness and Full Bloods at Admission sections removed

Stage 2 CRF:

  • Capture of Therapy Intensity Level amended to basic

Stage 3 CRF:

  • EQ5D-5L and EQ5D-5L Proxy combined to one form

Death Notification Form:

  • Please use this form when notifying us of a patient’s death


Please refer to the CRF Completion Guidelines v3.0 when completing CRFs. All updated CRFs are available online on our website (www.rescueasdh.org)


'The role of surgery in traumatic brain injury' is an open-access article until the 3rd of November. Please following the link for the full article: https://goo.gl/WGacjN
 


Additional Support for the RESCUE-ASDH Trial


If your centre requires...

  • a training session for the RESCUE-ASDH Trial

  • support or help with CRF completion

  • additional information regarding recruitment or administrative aspects of the trial

Please contact us at info@rescueasdh.org or get in touch with our study coordinator at +44 (0)1223 256624

The RESCUE-ASDH Training Presentation is now available online. Please click on the presentation below to navigate to the training website:
RANDOMISATION DETAILS
 
To not miss any eligible participant from being randomised, there are 3 different ways of randomisation in this trial:
  • For web based randomisation:   www.rescueasdh.org (enter username & password)
  • For phone based randomisation in the UK:  0800 2802 307 (enter site ID code)
  • Any questions about randomisation including patient eligibility, please contact our team: +44(0)1223 746452 (24/7)

Recruitment Details

  • Randomised: 129 patients
  • Observational cohort: 146 patients
  • RESCUE-ASDH monthly recruitment rates shown below:



Total recruitment by centre:
 
  Randomised Observational Total
Bart's (Royal London) 24 4 28
Cambridge 21 22 43
St Mary's Hospital, London 14 19 33
Southampton 12 18 30
Liverpool 7 12 19
Leeds 6 3 9
Middlesbrough 5 4 9
Manchester 5 3 8
Nottingham 5 2 7
Bristol 4 13 17
King’s College Hosp., London 4 12 16
Birmingham 4 7 11
Oxford 3 6 9
Plymouth 3 2 5
Preston 2 3 5
St George's Hospital, London 2 2 4
Cardiff 2 1 3
Newcastle 2 0 2
Brighton 1 4 5
Hull 1 2 3
Sheffield 1 0 1
Romford 1 0 1
Coventry 0 5 5
Dallas (UTSW) 0 2 2
Boston (BIDMC) 0 0 0
Edinburgh 0 0 0
Dundee 0 0 0
Glasgow 0 0 0
Total 129 146 275
@rescueasdh   www.rescueasdh.org   info@rescueasdh.org
Copyright © *|CURRENT_YEAR|* RESCUE-ASDH, All rights reserved.

Our mailing address is: 
RESCUE-ASDH
Box 167, Division of Neurosurgery, University of Cambridge, Cambridge Biomedical Campus
Addenbrooke's Hospital
Cambridge, Cambridgeshire CB2 0QQ
United Kingdom

Add us to your address book



Want to change how you receive these emails? You can update your preferences or unsubscribe from this list






This email was sent to <<Email Address>>
why did I get this?    unsubscribe from this list    update subscription preferences
RESCUE-ASDH · Box 167, Division of Neurosurgery, University of Cambridge, Cambridge Biomedical Campus · Addenbrooke's Hospital · Cambridge, Cambridgeshire CB2 0QQ · United Kingdom

Email Marketing Powered by Mailchimp